Egzista

Leaflet attached to the packaging: patient information

Egzysta, 25 mg, hard capsules
Egzysta, 50 mg, hard capsules
Egzysta, 75 mg, hard capsules
Egzysta, 100 mg, hard capsules
Egzysta, 150 mg, hard capsules
Egzysta, 200 mg, hard capsules
Egzysta, 225 mg, hard capsules
Egzysta, 300 mg, hard capsules
pregabalin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Egzysta and what is it used for
• 2. Important information before taking Egzysta
• 3. How to take Egzysta
• 4. Possible side effects
• 5. How to store Egzysta
• 6. Contents of the pack and other information

1. What is Egzysta and what is it used for

Egzysta belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder in adults.
Neuropathic pain of peripheral and central origin:Egzysta is used to treat long-term pain caused by nerve damage. Many different diseases, such as diabetes or shingles, can cause peripheral neuropathic pain.
The pain can be described as a feeling of heat, burning, throbbing, shooting, stabbing, sharp pain, cramps, aching, tingling, or numbness. Peripheral and central neuropathic pain can also be associated with mood changes, sleep disturbances, fatigue, which can affect the patient's physical and social functioning and overall quality of life.
Epilepsy:Egzysta is used to treat certain types of epilepsy (partial seizures, which may or may not be secondary generalized) in adults. The doctor may prescribe Egzysta if the current treatment does not fully control the disease. Egzysta should always be used as an add-on therapy to the currently used treatment. Egzysta should not be used as monotherapy, but always in combination with other antiepileptic drugs.
Generalized anxiety disorder:Egzysta is used to treat generalized anxiety disorder (GAD). The symptoms of GAD include prolonged, excessive anxiety and worry that are difficult to control. GAD can also cause restlessness, nervousness, or feeling on edge, easily becoming fatigued, difficulty concentrating or feeling of emptiness in the head, irritability, increased muscle tension, or sleep disturbances. The symptoms are different from the stresses and strains of everyday life.

2. Important information before taking Egzysta

When not to take Egzysta

If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Egzysta, discuss it with your doctor.

• Some patients taking Egzysta have experienced symptoms suggesting an allergic reaction. These symptoms included swelling of the face, lips, tongue, and throat, as well as a widespread skin rash. If any of these symptoms occur, contact your doctor immediately.
• Taking Egzysta has been associated with dizziness and drowsiness: this may lead to more frequent accidental injuries (falls) in elderly people. Therefore, caution should be exercised until the effects of the medicine are known.
• Taking Egzysta may cause blurred vision, loss of vision, or other vision disturbances, most of which are transient. If any changes in vision occur, inform your doctor immediately.
• In patients with diabetes who gain weight during pregabalin treatment, it may be necessary to adjust the antidiabetic treatment.
• Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may also take other medicines, e.g., painkillers or muscle relaxants, which have similar side effects to Egzysta, and the severity of these effects may be greater when such medicines are taken concomitantly.
• Reports of heart failure have been reported in some patients taking Egzysta; these were mainly elderly patients with cardiovascular disorders . Before taking this medicine, inform your doctor about any history of heart disease.
• Reports of kidney failure have been reported in some patients taking Egzysta. If, while taking Egzysta, the patient notices a decrease in urine frequency, they should inform their doctor, as stopping the medicine may cause the symptom to resolve.
• A small number of patients taking antiepileptic drugs, such as Egzysta, have had thoughts of self-harm or suicide, or have exhibited suicidal behavior. If the patient has ever had such thoughts or behaviors, they should contact their doctor immediately.
• If Egzysta is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal problems (e.g., constipation, obstruction, or paralysis of the intestines) may occur. Inform your doctor if you experience constipation, especially if you are prone to it.
• Before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or any illegal psychoactive substances; this may indicate an increased risk of dependence on Egzysta.
• Reports of seizures have been reported during Egzysta treatment or shortly after discontinuation of treatment. If seizures occur, contact your doctor immediately.
• Reports of brain function impairment (encephalopathy) have been reported in some patients with other diseases who took Egzysta. Inform your doctor about all serious diseases you have had, including liver or kidney disease.
• Reports of breathing difficulties have been reported. If you have nervous system disorders, respiratory disorders, kidney function disorders, or are over 65 years old, your doctor may recommend a different dosing schedule. If you experience breathing difficulties or shallow breathing, contact your doctor.
• Pregabalin has been associated with severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If you experience any of the serious skin reactions listed in section 4, discontinue pregabalin and seek medical attention immediately.
  Dependence
  Some people may become dependent on Egzysta (need to continue taking the medicine). After stopping Egzysta, withdrawal symptoms may occur (see section 3 "How to take Egzysta" and "Stopping Egzysta"). If you are concerned that you may become dependent on Egzysta, you should discuss this with your doctor.
  If, while taking Egzysta, you notice any of the following symptoms, it may indicate dependence:
  • Need to take the medicine for a longer period than prescribed by the doctor
  • Feeling the need to take a higher dose than prescribed
  • Taking the medicine for reasons other than prescribed
  • Repeatedly attempting to stop taking or control the use of the medicine
  • Feeling unwell after stopping the medicine and feeling better after taking it again If you notice any of these symptoms, you should discuss them with your doctor to determine the best course of treatment, including when to stop taking the medicine and how to do it safely.

  Children and adolescents

  The safety and efficacy of pregabalin in children and adolescents (under 18 years of age) have not been established, so Egzysta should not be used in this age group.

  Egzysta and other medicines

  Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
  Egzysta and some medicines may interact with each other (interactions). Egzysta taken with other sedating medicines (e.g., opioids) may enhance the sedating effects and lead to respiratory failure, coma, and death. The degree of dizziness, drowsiness, and decreased concentration may increase if Egzysta is taken with medicines containing:

  • oxycodone - (painkiller)
  • lorazepam - (medicine used in anxiety states)
  • alcohol

  Egzysta can be taken with oral contraceptives.

  Egzysta with food, drink, and alcohol

  Egzysta capsules can be taken with or without food.
  Do not drink alcohol while taking Egzysta.

  Pregnancy and breastfeeding

  Egzysta should not be taken during pregnancy or breastfeeding, unless your doctor decides otherwise. Taking pregabalin during the first 3 months of pregnancy may cause birth defects in the unborn baby. In a Scandinavian study, analysis of data from women who took pregabalin during the first 3 months of pregnancy showed birth defects in 6 out of every 100 babies born, whereas in women who were not treated with pregabalin, birth defects occurred in 4 out of every 100 babies born. The reported birth defects included facial defects (cleft lip and palate), eye defects, nervous system defects (including brain defects), kidney defects, and genital defects.
  Women of childbearing age should use effective contraception.
  If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  Driving and using machines

  Egzysta may cause dizziness, drowsiness, and decreased concentration. Do not drive a car, operate complex machines, or perform potentially hazardous activities until you have determined the effect of this medicine on your ability to perform these activities.

  Egzysta contains lactose monohydrate

  If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

  3. How to take Egzysta

  Take this medicine always as directed by your doctor. If you are not sure, ask your doctor or pharmacist. Do not take more of the medicine than prescribed.
  Your doctor will determine the dose that is right for you.
  Egzysta is for oral use only.
  Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:

  • Take the number of capsules as directed by your doctor.
  • The dose recommended for you will be between 150 mg and 600 mg per day.
  • Your doctor will tell you whether to take Egzysta twice or three times a day. If taken twice a day, Egzysta should be taken in the morning and evening at the same time every day. If taken three times a day, Egzysta should be taken in the morning, at noon, and in the evening at the same time every day.

  If you feel that the effect of Egzysta is too strong or too weak, talk to your doctor or pharmacist.
  Patient over 65 years should take Egzysta as presented, unless they have kidney problems.
  In patients with impaired kidney function, the doctor may decide on a different dosing schedule and/or adjust the dose of the medicine.
  The capsule should be swallowed whole with water.
  Egzysta should be taken for as long as your doctor prescribes, and the treatment can only be stopped on the doctor's advice.

  Taking a higher dose of Egzysta than recommended

  Tell your doctor or go to the nearest hospital emergency department immediately. Take the medicine pack or bottle with you. After taking a higher dose of Egzysta than recommended, you may feel drowsy, confused, excited, or restless. There have also been reports of seizures and loss of consciousness (coma).

  Missing a dose of Egzysta

  It is important to take Egzysta regularly at the same times every day. If you miss a dose, take it as soon as you remember, unless it is almost time for the next dose. In this case, continue treatment as prescribed. Do not take a double dose to make up for a missed dose.

  Stopping Egzysta treatment

  Do not stop taking Egzysta suddenly. If you want to stop taking Egzysta, talk to your doctor first. The doctor will tell you how to do it.
  If treatment needs to be stopped, it should be done gradually over at least one week.
  You should be aware that after stopping short- or long-term treatment with Egzysta, certain side effects may occur, known as withdrawal symptoms. These symptoms include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, excessive sweating, and dizziness. These symptoms may be more frequent or severe if you have taken Egzysta for a long time. If you experience withdrawal symptoms, contact your doctor.
  If you have any further questions about taking this medicine, ask your doctor or pharmacist.

  4. Possible side effects

  Like all medicines, Egzysta can cause side effects, although not everybody gets them.

  Very common - may affect more than 1 in 10 people:

  Dizziness, drowsiness, headaches

  Common - may affect up to 1 in 10 people:

  • Increased appetite
  • Mood elevation, confusion, disorientation, decreased sexual interest, irritability
  • Difficulty concentrating, clumsiness, memory impairment, memory loss, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling of abnormality
  • Blurred vision, double vision
  • Dizziness, balance disturbances, falls
  • Dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension
  • Difficulty achieving an erection
  • Body swelling, including limb swelling
  • Feeling of intoxication, ataxia
  • Weight gain
  • Muscle spasms, joint pain, back pain, limb pain
  • Sore throat

  Uncommon - may affect up to 1 in 100 people:

  • Loss of appetite, weight loss, low blood sugar, high blood sugar
  • Changes in self-perception, restlessness, depression, excitement, mood swings, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychotic disorders, difficulty thinking, increased sexual interest, sexual problems, including inability to achieve orgasm, delayed ejaculation
  • Changes in vision, abnormal eye movements, vision disturbances, including tunnel vision, flashes of light, nystagmus, decreased reflexes, increased activity, dizziness when standing up, skin hypersensitivity, loss of taste, burning sensation, tremor when moving, impaired consciousness, loss of consciousness, syncope, increased sensitivity to noise, malaise
  • Dry eyes, eye swelling, eye pain, decreased eye movements, lacrimation, eye irritation
  • Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
  • Sudden flushing of the skin, sudden hot flashes
  • Breathing difficulties, feeling of dryness in the nose, feeling of a blocked nose
  • Increased salivation, heartburn, feeling of numbness around the mouth
  • Sweating, rash, chills, fever
  • Muscle tremors, joint swelling, muscle stiffness, pain, including muscle pain, neck pain
  • Chest pain
  • Difficulty urinating or painful urination, urinary incontinence
  • Weakness, thirst, chest tightness
  • Changes in blood test results and liver function (increased creatine phosphokinase activity, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels in the blood, decreased potassium levels in the blood)
  • Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, coughing, snoring
  • Painful menstruation
  • Cold hands and feet

  Rare - may affect up to 1 in 1,000 people:

  • Changed sense of smell, feeling of rocking, changed sense of depth, bright vision, loss of vision
  • Dilated pupils, strabismus
  • Cold sweats, throat constriction, tongue swelling
  • Pancreatitis
  • Difficulty swallowing
  • Slowed or limited movements
  • Difficulty writing
  • Ascites
  • Fluid in the lungs
  • Seizures
  • Changes in ECG corresponding to heart rhythm disturbances
  • Muscle damage
  • Breast discharge, breast enlargement, gynecomastia
  • Amenorrhea
  • Kidney failure, decreased urine output, urinary retention
  • Decreased white blood cell count
  • Inappropriate behavior, suicidal behavior, suicidal thoughts
  • Allergic reactions, which may be characterized by difficulty breathing, eye inflammation (keratitis), and severe skin reactions characterized by red, flat, plate-like, or round patches on the torso, often with blisters in their centers, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of such serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Jaundice (yellowing of the skin and whites of the eyes)
  • Parkinsonian syndrome, i.e., symptoms similar to Parkinson's disease, such as tremors, slowed movement (decreased ability to move), and stiffness (muscle stiffness)

  Very rare - may affect up to 1 in 10,000 people:

  • Liver failure
  • Hepatitis

  Frequency not known: frequency cannot be estimated from the available data

  • Dependence on Egzysta ("drug dependence")

  Be aware that after stopping short- or long-term treatment with Egzysta, certain side effects may occur, known as withdrawal symptoms (see section "Stopping Egzysta treatment").

  If you experience facial swelling or tongue swelling, or if a skin rash with blisters or peeling occurs, seek medical attention immediately.

  Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may also take other medicines, e.g., painkillers or muscle relaxants, which have similar side effects to Egzysta, and the severity of these effects may be greater when such medicines are taken concomitantly.
  After the medicine was placed on the market, the following side effect was also reported: breathing difficulties, shallow breathing.

  Reporting side effects

  If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
  Jerozolimskie Avenue 181C
  02-222 Warsaw
  tel.: 22 49-21-301
  fax: 22 49-21-309
  Website: https://smz.ezdrowie.gov.pl
  Side effects can also be reported to the marketing authorization holder.
  By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store Egzysta

  Keep the medicine out of the sight and reach of children.
  Do not use this medicine after the expiry date stated on the carton after EXP.
  The expiry date refers to the last day of the month stated.
  Store below 30°C. Store in the original package to protect from light.
  Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

  6. Contents of the pack and other information

  What Egzysta contains

  The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, or 300 mg of pregabalin.
  The other ingredients are: lactose monohydrate, maize starch, talc, gelatin, titanium dioxide (E171),

  • iron oxide black (E172) for 25 mg capsules
  • iron oxide yellow (E172) for 50 mg, 200 mg, 225 mg capsules
  • iron oxide red (E172) for 75 mg, 100 mg, 200 mg, 225 mg, 300 mg capsules,
  • black ink (containing: shellac, iron oxide black (E 172), propylene glycol, ammonia solution, 28% concentration) for 75 mg, 100 mg, 225 mg capsules.

  What Egzysta looks like and contents of the pack

  Egzysta 25 mg, hard capsules
  Hard gelatin capsules, size 4, cap and body: opaque, gray. Capsule contents: white or almost white powder.
  Egzysta 50 mg, hard capsules
  Hard gelatin capsules, size 3, cap and body: opaque, light beige.
  Egzysta 75 mg, hard capsules
  Hard gelatin capsules, size 4, cap: opaque, reddish-brown; body: opaque, white with black inscription "75 mg". Capsule contents: white or almost white powder.
  Egzysta 100 mg, hard capsules
  Hard gelatin capsules, size 3, cap: opaque, reddish-brown; body: opaque, reddish-brown with black inscription "100 mg". Capsule contents: white or almost white powder.
  Egzysta 150 mg, hard capsules
  Hard gelatin capsules, size 2, cap and body: opaque, white. Capsule contents: white or almost white powder.
  Egzysta 200 mg, hard capsules
  Hard gelatin capsules, size 1, cap and body: opaque, caramel. Capsule contents: white or almost white powder.
  Egzysta 225 mg, hard capsules
  Hard gelatin capsules, size 0, cap: opaque, caramel; body: opaque, caramel with black inscription "225 mg". Capsule contents: white or almost white powder.
  Egzysta 300 mg, hard capsules
  Hard gelatin capsules, size 0, cap: opaque, reddish-brown; body: opaque, white. Capsule contents: white or almost white powder.
  Egzysta is available in packs of 14, 20, 28, 50, 56, 98 hard capsules.
  Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Marketing authorization holder

  Adamed Pharma S.A.
  Pieńków, ul. M. Adamkiewicza 6A
  05-152 Czosnów

  Manufacturer/Importer

  Adamed Pharma S.A.
  ul. Marszałka Józefa Piłsudskiego 5
  95-200 Pabianice
  To obtain more detailed information on the medicine, contact the local representative of the marketing authorization holder:
  Adamed Pharma S.A.
  Pieńków, ul. M. Adamkiewicza 6A
  05-152 Czosnów

  Date of last revision of the leaflet: 08.2025